Tango Therapeutics Inc. CEO Barbara Weber told BioWorld that Gilead Sciences Inc.’s decision to greatly expand their 2018 deal in oncology – a pact then valued as high as $1.7 billion – was based on brisker than expected progress in the original, five-target effort. Read More
Following a patient’s death in Poseida Therapeutics Inc.’s phase I trial of P-PSMA-101 in metastatic castrate-resistant prostate cancer (mCRPC), the FDA has put the study on clinical hold. Read More
A first half of the year progress report from the international advocacy group Alliance for Regenerative Medicine (ARM), finds that the regenerative medicine and advanced therapy sector is in very good shape and has performed well in terms of both clinical development and fundraising despite the challenges posed by the ongoing COVID-19 pandemic. Read More
The FDA’s bright line between orphan designation and exclusivity was erased, again, Monday for some drugs when the U.S. Court of Appeals for the District of Columbia denied the agency an en banc rehearing of Eagle Pharmaceuticals Inc. v. Alex Azar. Read More
LONDON – A pan-European consortium backed by 11 pharma companies is pooling resources in a €77.7 million (US$92.5 million) five-year plan to advance development of therapeutics for COVID-19 and other coronaviruses. Read More
HONG KONG – China’s Lianyungang-based Jiangsu Hengrui Medicine Co. Ltd. has obtained approval from Korea’s Ministry of Food and Drug Safety (MFDS) to begin a phase III trial for a combination therapy of its PD-1 inhibitor candidate camrelizumab and VEGFR-2 inhibitor rivoceranib. Read More
HONG KONG – Huya Bioscience International LLC, which has a special interest in China-developed assets, has obtained an exclusive global license, bar China, for the SHP2 inhibitor HBI-2376 from Suzhou-based Genhouse Pharmaceutical Co. Ltd. Financial terms were not disclosed. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acepodia, Aligos, Arrowhead, Clovis, Deciphera, Follicum, GSK, Immatics, Immunicum, Immutep, Intravacc, Maxcyte, Novartis, Organicell, Poseida, Telix, The University of Texas MD Anderson Cancer Center, Ultimovacs, Vanda. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Emmaus, Immatics, Kimera, Krystal. Read More
